Recall of Device Recall Vintage Total Ankle Tibia Insert

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.

Possible inner labeling and packaged device not matching the outer label on the box.

Action

Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. For further questions, please call (352) 377-1140.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.